"Over the years, BIO-CAT has had the good fortune to hire excellent people to run our operation."

- Ed Schuler, BIO-CAT CEO and Founder

Regulatory

The Regulatory Department at BIO-CAT Microbials provides our customers with regulation review and assistance, product and consumer safety information, import/export support, and other ad hoc services. Specifically, the services include the provision of documentation to customers to support their regulatory compliance files:

GRAS Statements

Allergen Statements

Certificates of Origin

Animal Derivative, BSE/TSE Statements

Composition Statements

GMO Statements

HALAL certification; as issued under Islamic Laws by the Islamic Food and Nutrition Council of America (IFANCA®)

Kosher Status certification; as issued by the Kashruth Division of the Orthodox Union (OU)

Harmonized Tariff Schedule

Irradiation/Ionization Statement

Melamine Statements

Nutritional Statements

Organic Statements

Vegetarian/Vegan Statements

Safety Data Sheets

BIO-CAT Microbials supports our customers with registration processes to relevant regulatory bodies. Regulatory authorities that we have worked with recently include the Canadian Health Authorities, OMRI, Environmental Protection Agency and TGA. Additionally, we have experience in managing clinical trials with the generation of Good Clinical Practice Technical Agreements as per ICH Q6 R1 both for BIO-CAT Microbials and our customers where needed.

The Regulatory team at BIO-CAT Microbials works closely with various industry groups such as the Enzyme Technical Association (ETA), the American Feed Industry Association (AFIA), the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA), to name a few.

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